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Risedronate/Cholecalciferol combination
Risedronate inhibits bone resorption by blocking osteoclast activity, while cholecalciferol (vitamin D3) enhances calcium absorption and supports bone mineralization.
Risedronate inhibits bone resorption by blocking osteoclast activity, while cholecalciferol (vitamin D3) enhances calcium absorption and supports bone mineralization. Used for Osteoporosis in postmenopausal women, Osteoporosis in men, Glucocorticoid-induced osteoporosis.
At a glance
| Generic name | Risedronate/Cholecalciferol combination |
|---|---|
| Also known as | RisenexPlus tablet |
| Sponsor | Hanlim Pharm. Co., Ltd. |
| Drug class | Bisphosphonate + vitamin D3 combination |
| Target | Osteoclast farnesyl pyrophosphate synthase (risedronate); vitamin D receptor (cholecalciferol) |
| Modality | Small molecule |
| Therapeutic area | Bone metabolism / Osteoporosis |
| Phase | FDA-approved |
Mechanism of action
Risedronate is a bisphosphonate that binds to hydroxyapatite in bone and inhibits farnesyl pyrophosphate synthase in osteoclasts, reducing bone turnover. Cholecalciferol (vitamin D3) increases intestinal calcium absorption and promotes bone mineralization, complementing the antiresorptive effect of risedronate. Together, they work synergistically to increase bone mineral density and reduce fracture risk.
Approved indications
- Osteoporosis in postmenopausal women
- Osteoporosis in men
- Glucocorticoid-induced osteoporosis
Common side effects
- Gastrointestinal irritation (esophageal, gastric)
- Musculoskeletal pain
- Headache
- Hypercalcemia (with excessive vitamin D)
Key clinical trials
- Bone Turnover Markers and Treatment Efficacy in Postmenopausal Osteoporosis (NA)
- Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women (PHASE4)
- Prevention of Osteoporosis in Breast Cancer Survivors (NA)
- Efficacy and Safety Study of Risedronate, Cholecalciferol Combination Tablet in Patients With Osteoporosis (PHASE4)
- To Evaluate the Efficacy and the Safety of Monthly Versus Weekly Oral Risedronate With Vitamin D in Compliance, Improvement of Vitamin D and BMD in Korean Postmenopausal Osteoporotic Women (PHASE4)
- Post-menopausal Women Osteoporosis(Phase III) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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